Study of Acalabrutinib versus Chlorambucil plus Rituximab in Adult Subjects with Previously Untreated Chronic Lymphocytic Leukemia

Exclusion Criteria

• - Known detected del(17p) or TP53 mutation
• - Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (eg, Richter’s transformation, PLL, or diffuse large B cell lymphoma [DLBCL]), or central nervous system (CNS) involvement by leukemia
• - History of prior malignancy except for the following: (a) Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study (b) Other cancers not specified above which have been curatively treated by surgery and/or radiation therapy from which subject is disease-free for ≥3 years without further treatment
• - Significant cardiovascular disease
• - Known history of infection with human immunodeficiency virus (HIV)
• - Serologic status reflecting active hepatitis B or C infection
• - Any active systemic infection (eg, bacterial, viral, or fungal infection) requiring systemic treatment
• - History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
• - Major surgical procedure within 30 days of first dose of study drug
• - Any prior CLL-specific therapies
• - Corticosteroid use >20 mg within 1 week before first dose of study drug, except as indicated for other medical conditions
• - Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists
• - For women only: breastfeeding or pregnant